9 results
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18ms
·
Sources: EU EUDAMED, US FDA
L(3), LYSNIG LEAD LATEX RADIATION GLOVE(R)
FDA 510(k)
FDA Class 1
·General Hospital
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756657464·INTRAVITREAL INJECTION KIT I
DISPOSABLE TRANSDUCER MANIFOLD
FDA 510(k)
FDA Class 2
·Cardiovascular
ORTHOTRAK
FDA 510(k)
FDA Class 2
·Physical Medicine
NATURALYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·June 13, 2014
EPIC PLUS VR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·November 10, 2010
9600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·December 10, 2012
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024